PUTTING IT ALL TOGETHER: Practical Approach Knee OA Patients Interested in Regenerative Medicine

PUTTING IT ALL TOGETHER: Practical Approach Knee OA Patients Interested in Regenerative Medicine Jay Smith, MD Professor & Vice-Chair of of PM&R Departments of PM&R, Radiology & Anatomy Mayo Clinic, Rochester, MN AAPM&R 2015

REGEN MED CONSULTDisclosures • Off-label use • PRP, BMC • Speaking honorarium • Gulf Coast Ultrasound Institute • Stock/Royalties–TENEX Health • Stock/CMO –Sonex Health

REGEN MED CONSULTLearning Objectives • Discuss approach to patient with knee OA interested in regenerative medicine options • Practical • Patient encounter • Best available science • Level V evidence • Focus on PRP & BMC • Prolotherapy • Structural fat grafts • Other AMSCs – Mayo

REGEN MED CONSULTClinical Presentation • 60 y Male with left knee OA • ‘’Can those stem cells cure my arthritis?” • “Dr. X said you can regrow my cartilage.”

REGEN MED CONSULTBe a Good Doctor  Perform a comprehensive physiatric evaluation • Confirm diagnosis • Ensure reasonable prior Rx • Standard of care • Identify co-morbidities • Influence regen med options • Modify expected outcomes • Determine functional limitations & patient goals • “What do you want to achieve?”

REGEN MED CONSULTHistory: Sx Profile & Past Eval • Presenting symptoms • Functional consequences • Prior evaluation • Prior imaging • Standing X-rays < 1 yr • Alignment • MRI? • Bone marrow lesions • Meniscal extrusion

REGEN MED CONSULTHistory: Assess Prior Treatments • Activity modification • Weight loss • PT/Exercise • Strength • Aerobics • Other • Bracing/Wedges • Modalities • PEMF, TENS, etc. • Meds • Oral • Topical • Supplements • Injections • Cortisone • Hyaluronic acid • Regen • Surgery Underline – AAOS Guidelines

REGEN MED CONSULTHistory: Prior Treatments – Why? • Identify and discuss gaps in prior treatments • Reinforce importance of holistic approach • (Re)-implement prior to regen med • Integrate into regen med Rx plan • Assess patient’s dedication • Identify prior adverse reactions • Needle/procedure-phobic • Reaction to prior regen Rx

REGEN MED CONSULTHistory: Importance of Medical Hx • May benefit from “medical tune-up” first • Metabolic syndrome = pro-inflammatory • Disclose limited knowledge & experience • Safety of PRP & BMC reasonably established • Systemic inflammatory/autoimmune D/O’s? • Chronic infections (e.g. HIV, Hepatitis)? • Hematological (incl. marrow) disorders? • History of cancer?  Honest discussion & documentation  Discuss/obtain permission from caregivers

REGEN MED CONSULTHistory: Medications/Supplements • PRP • Avoid NSAIDs 1-2 weeks before (?after?) • Others? • BMC (BMSCs) • Immunosuppressives • Statins • Others?  Recommend common sense approach  Consider risks-benefits of medication changes

REGEN MED CONSULTHistory: Final Considerations • Document date of last physical examination • < 1 year • Screening tests • Lab tests • Communicate with caregiver • “Permission” • Medication modifications • Further evaluations

REGEN MED CONSULTPhysical Examination • Knee • Gait • Alignment • Motion loss • Instability • Mechanical Sxs • Hip/Spine/Neuro • Be sure it is a regen med treatable knee problem • Tendinosis, CPPD/gout, saphenous neuritis

REGEN MED CONSULTImaging • Standing radiographs • K-L staging • Alignment • MRI • Bone marrow lesions • May be painful • Recognized & treated? • Osteonecrosis • Meniscal extrusion? Choi Eur J Orthop Surg Traum 2014

REGEN MED CONSULTDiscussion & Treatment Options  Discuss diagnosis & Rx options • Review “standard of care” Rx options • Context of prior Rx • Do nothing  surgery • Review regen med Rx options • Off-label, non-reimbursed • Discuss patient specific options: • Evaluation • Patient preferences • Patient goals

REGEN MED CONSULTRx Options: Standard of Care • Consider “standard of care” options • Lateral wedge/brace • Trial of crutches (e.g. BML) • “Need quick fix” – cortisone • Preparation for later regen Rx • Surgery may be best option

REGEN MED CONSULTRx Options: PRP • Discuss rationale, preparation & delivery • Multiple studies, including RCTs • Reasonably safe • Physiologic > Regenerative • Slower onset vs. cortisone • 40-60% improvement X 6-12 mos. • May be better in K-L 1-2 • Can be repeated (long term safety?)

REGEN MED CONSULTRx Options: BMC • Discuss rationale, preparation & delivery • CE vs. BMC/BM-MNCs • Details regarding BMA • Few studies, no RCTs • Reasonably safe • Mechanism of action? • Potential disease modification • Expanded vs. BMC/BM-MNCs

REGEN MED CONSULTRx Options: BMC • 50% chance of > 50% improvement • 50-60% improvement (wide variability) • Not all respond • May be slow onset (> 3 months) • Max improvement 3-6 months • Durability?, but hope > 12 months • Can be repeated, long term safety? • More effective in K-L 3-4 vs. PRP?

REGEN MED CONSULTDecision-Making & Documentation • Discuss off-label use of PRP and BMC • Discuss FDA positions (e.g. SVF) • Discuss non-coverage by third party payors • ABNs/Waivers • Set realistic expectations • Be honest • Under-promise & over-deliver • “At worst it’s a waste of time and money” • Document

REGEN MED CONSULT THANK YOU Questions & Discussion

PUTTING IT ALL TOGETHER: Practical Approach Knee OA Patients Interested in Regenerative Medicine